DEVICE: DRS. ROLLER/KWON ROUX EN Y PACK (30607915134144)
Device Identifier (DI) Information
DRS. ROLLER/KWON ROUX EN Y PACK
K2707
In Commercial Distribution
APPLIED MEDICAL RESOURCES CORPORATION
K2707
In Commercial Distribution
APPLIED MEDICAL RESOURCES CORPORATION
Kit Contains:
CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
CTR03, 5x100 Kii® OPT ZTHR 6/BX
CA090, DIRECT DRIVE® LCA 3/BX
CB040, 5mmx45cm EPIX® LAPA SCISSOR, 10/BX
CTR73 12X100 Kii® OPT ZTHR 6/BX
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
42412 | Laparoscopic access cannula, single-use |
A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.
|
Active | false |
58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use |
An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.
|
Active | false |
35649 | Ligation clip, metallic |
A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HET | Laparoscope, Gynecologic (And Accessories) |
GCJ | Laparoscope, General & Plastic Surgery |
FZP | Clip, Implantable |
MDM | Instrument, Manual, Surgical, General Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
30c6951e-a8f7-4974-b186-89b7e9a55e83
August 07, 2024
6
October 16, 2015
August 07, 2024
6
October 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1.949.713.8300
contact@appliedmedical.com
contact@appliedmedical.com